MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3851

Device Problems Material Rupture (1546); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.During a procedure involving a 10mmx2.50mm wolverine coronary cutting balloon, a blade got caught on a guidezilla guide catheter and the balloon was damaged.The device was removed and the procedure completed with a different device.No patient complications were reported and the patient was good post procedure.

Manufacturer Narrative

Device evaluated by mfr: the wolverine cb mr, ous 10 mm x 2.50 mm device was returned for analysis.A visual examination identified that the balloon folds were relaxed.A microscopic examination identified a balloon longitudinal tear starting approximately 1mm from the distal end of the proximal markerband extending for a length of approximately 1 mm distally.This type of damage most likely occurred due to the interaction of the device (the blade) and the guidezilla guide catheter extension.The markerbands, blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination found a shaft polymer extrusion kink at approximately 100 mm distal of the mid-shaft/hypotube bond.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination found no issues with the hypotube shaft of the device that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon rupture occurred.During a procedure involving a 10mmx2.50mm wolverine coronary cutting balloon, a blade got caught on a guidezilla guide catheter and the balloon was damaged.The device was removed and the procedure completed with a different device.No patient complications were reported and the patient was good post procedure.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9234973
• MDR Text Key: 166982909
• Report Number: 2134265-2019-12863
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0024022058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE EXTENSION CATHETER: GUIDEZILLA; GUIDE EXTENSION CATHETER: GUIDEZILLA